Angulated rings and bonded foils for use with balloons for fusion and dynamic stabilization

ABSTRACT

An inflatable and implantable balloon for treatment of degenerative disc disease, bones, lesions, spinal deformities and spinal motion segment instabilities. The balloon is comprised of adjustable and expandable volumes. Further disclosed are methods of forming, inserting, expanding, and implanting the multi-volume balloon for proper placement and stabilization of the spinal lesion or disease. Still further disclosed are kits for aligning and stabilizing elements of the spine.

TECHNICAL FIELD

The technical field relates generally to inflatable and implantableballoons for treating degenerative disc disease, bone lesions, spinaldeformities and spinal motion segment instabilities, and, moreparticularly, to adjustable balloons and methods of using the adjustableballoons within the intervertebral disc space, vertebral bodies,interspinous processes, or any spinal elements, to aim at restoring theoriginal anatomy of the vertebral column.

BACKGROUND

Expandable medical devices, for example balloons, are commonly used fordilating and unblocking clogged or narrowed arteries (angioplasty). Morerecently, balloons have been used in surgical contexts other thanangioplasty because the implants can be introduced into a surgical sitewith a reduced profile to minimize disruption of the surroundingtissues, nerves, and blood vessels.

In the context of vertebral reconstruction, balloons could beparticularly useful. Vertebral reconstruction procedures, includingpercutaneous procedures such as kyphoplasty or vertebral body stenting,are used to correct a fractured vertebrae, a spinal deformity, or spinalinstability, while intervertebral procedures, such as open surgeryspinal fusion procedures, are used to correct the loss of disc heightdue to degenerative or herniated discs. Balloons using percutaneousprocedures are not yet known to be commonly used in spinal fusion andintervertebral disc replacement procedures. Classic spinal fusionprocedures are often effective to restore proper vertebral spacing andtherefore relieve pressure on nerves and consequent pain, despite thehuge open wounds and subsequent surgical trauma involved.

A problem with currently used fusion procedures occurs when twovertebral bodies are fused together because eventually the lack of anintervertebral disc between the two fused vertebral bodies overloads theadjacent intervertebral discs accelerating the degeneration of theseadjacent discs. One treatment option is an intervertebral discreplacement, such as a prosthetic disc. This procedure is also used inpatients with degenerative or herniated discs. A problem associated witha prosthetic disc is the vertebral bodies may need varying support indifferent locations. Pressure distribution on the damaged intervertebraldisc may no longer be uniform, due to the years of damage to the spinethat typically occurs before surgery is considered. Therefore, aprosthetic disc may not provide the necessary support to the vertebralbodies.

Another issue related to use of implants is that diseases, such asdegenerative disc disease (DDD), are dynamic diseases: theintervertebral disc degenerates progressively and presents a variety ofsymptoms, and therefore treatment options. Disc degeneration is a normalpart of the aging process and may not be an issue for a normal person.For an individual with DDD, however, a degenerated disc can cause severechronic pain and lead to chronic debilitating conditions if leftuntreated. In some patients, DDD can be treated without surgery, but ifnon-surgical treatment options are unsuccessful, surgery is typicallyrecommended. The surgical option selected for a patient depends on thestage of disc degeneration, i.e., early-, mid-, or late-stages ofdegeneration. Some examples of surgical procedures include: discectomy,corpectomy, fusion, dynamic stabilization, intervertebral discarthroplasty (also called Artificial Disc Replacement (ADR)), and spinaldecompression. Once traditional surgical procedures, such as fusion, areused to treat DDD, there is an increased rate of re-operation forpatients to treat additional problems associated with DDD. One solutionto this problem is to provide a method of treatment for DDD that allowsa patient to retain mobility and preserve the range of motion tominimize the need for re-operation.

As one skilled in the related art would readily appreciate, there is acontinuing need for new and innovative expandable medical implants andinsertion devices directed toward the treatment of diseased and damagedbones and discs. More specifically, there exists a need for expandablemedical implants that provide maximum support and ease of positioningwithin a cavity of bone and/or the disc space.

SUMMARY

To meet these and other needs, and in view of its purposes, thedisclosure provides a multi-volume balloon for treating the clinicalconsequences of degenerative disc disease, vertebral body bone defects,and spinal motion segment instability. The balloon has a plurality ofsingle volumes. The single volumes are each connected, directly orindirectly, to one another and contain a perforation site between atleast two of the single volumes. Each single volume is individuallyadjustable and expandable such that (a) each single volume can contain avariable volume of contents, and (b) each of the plurality of singlevolumes can contain the same, or a different, amount and type ofcontents relative to another single volume.

The balloon of another embodiment has at least two pieces of materialthat are bonded together to form a balloon. The material of the ballooncontains marks; the marks can be bonded together to form at least twocompartments in the balloon.

The present application also provides several methods for treating theclinical consequences of degenerative disc disease, vertebral body bonedefects, and spinal motion segment instability. In one embodiment, themethod involves angling a single-volume balloon to create a multi-volumeballoon. More specifically, the method includes the step of providing asingle-volume balloon and at least one ring. The ring has two ends andthe ends of the ring are set to a predetermined angle. The single-volumeballoon is inserted into the ring. The ring containing the single-volumeballoon is inserted into a cavity of a vertebral column, wherein thecavity is an intervertebral disc space or a vertebral body. Thesingle-volume balloon is expanded, wherein the expansion of thesingle-volume balloon within the ring forms a multi-volume balloon withthe predetermined angle of the ring determining the angulation of eachvolume of the multi-volume balloon.

The method of another embodiment involves aligning and stabilizing avertebral column. The method includes the step of inserting aballoon-catheter containing a multi-volume balloon, wherein themulti-volume balloon is located at the distal end of theballoon-catheter, into a cavity of a vertebral column, wherein thecavity is an intervertebral disc space or a vertebral body. A firstvolume of the multi-volume balloon is expanded by inserting a fluid,wherein the expansion of the first volume restores height to thevertebral column. A second volume of the multi-volume balloon isexpanded by inserting a solidifying material, wherein the solidifyingmaterial hardens after insertion to maintain the height restorationcreated by the expansion of the first volume.

The method of yet another embodiment involves inserting a balloon into acavity of a patient. The method includes the step of rolling the ballooninto a tubular shape. The balloon is then inserted into the cavity ofthe patient, wherein the cavity was cleared prior to insertion of theballoon. Once inside the cavity, the balloon is unfurled.

The present application also provides several kits for aligning andstabilizing bone. In one embodiment, the kit has at least onesingle-volume balloon and at least one ring. Each ring has two ends. Theends of the ring are set to a predetermined angle. When thesingle-volume balloon is inserted into the ring, inflating thesingle-volume balloon containing the ring creates a multi-volumeballoon. The predetermined angle of the ring determines the angulationof each volume of the multi-volume balloon.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary, but are notrestrictive, of the embodiments of the present application.

BRIEF DESCRIPTION OF THE DRAWING

The foregoing summary, as well as the following detailed description ofillustrative embodiments, are best understood when read in connectionwith the accompanying drawing. It is emphasized that, according tocommon practice, the various features of the drawing are not to scale.On the contrary, the dimensions of the various features are arbitrarilyexpanded or reduced for clarity. Included in the drawing are thefollowing figures:

FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, and 1K show perspectiveviews of a kit used to form a multi-volume balloon from a single-volumeballoon according to an embodiment;

FIGS. 2A and 2B show perspective views of a single or multi-volumeballoon according to another embodiment;

FIG. 3 shows a perspective view of a single or multi-volume balloonaccording to another embodiment;

FIGS. 4A and 4B are perspective views of a multi-volume balloonaccording to another embodiment; and

FIGS. 5A and 5B are perspective views of a multi-volume balloonaccording to another embodiment.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right,” “left,” “lower,” and“upper” designate directions in the figures to which reference is made.The words “inwardly” and “outwardly” refer to directions toward and awayfrom, respectively, the geometric center of the multi-volume balloon.The words “anterior,” “posterior,” “superior,” “inferior,” and relatedwords or phrases designate preferred positions and orientations in thehuman body to which reference is made and are not meant to be limiting.The terminology includes the above-listed words, derivatives of thosewords, and words of similar import.

The clinical consequences of degenerative disc disease, vertebral bodybone defects, and spinal motion segment instability can be treated byeither restoring height to the intervertebral disc or by stabilizing thevertebral body. Treatment addresses a lesion zone “cavity” within thevertebral column. A cavity can include either the space previouslyoccupied by the intervertebral disc, a space within a vertebral body, orboth. The balloons reclaim both the disc space (i.e., they act as discspacers) and the disc itself; the balloons are customized to provide theideal shape to restore the anatomy of the patient. The balloons maintainthe dampening function of the disc spacers and protect adjacent levels.In some embodiments, the balloons can assist in the fusion of any twobodies, preferably vertebral bodies.

In some embodiments, the balloon is a multi-volume balloon. A benefit ofthe multi-volume balloon approach to stabilization and fusion ofvertebral bodies is that a surgeon, or caregiver, can adjust and specifythe individual volumes of the multi-volume balloon to provide maximumstabilization within a cavity of the vertebral column, i.e., improvedstabilization to reduce the risk of subsidence due to a better loaddistribution and improved manipulation options for an optimized spinalrealignment. For example, if a degenerative disc results in a vertebralbody sloping inferiorly on the left side of the patient's body, a singlevolume of the multi-volume balloon supporting that area need not be asinflated as a single volume of the multi-volume balloon on the rightside of the patient's body. The embodiments of the multi-volume balloonprovide for individualized, variable, and adjustable volumes of supportfrom the multi-volume balloon. Further, a single volume balloon, forinstance, may provide support in the center of the vertebral body, theweakest part of the bone. The multi-volume balloon provides support onan individualized basis but can target the peripheral edges of thevertebral bone to support the bone where it is most durable.

In other embodiments, the balloon, either a single volume balloon ormulti-volume balloon, is made up of at least two pieces of foil or meshbonded, or welded, together. The foil or mesh may be made of metal,polymers, or any other material discussed below. The bonding process, orwelding process, can be accomplished by any method, such as, forexample: ultrasonic welding, thermal welding using either a heat orlight source, pressure welding (for example, by using clamps, jaws,chucks, or shrink tubing), swaging, joining, gluing, and stitching. Theterms “bonded” and “welded” may be interchangeably used herein. Thebenefit of using materials such as these bonded together is that itincreases the flexibility of the shape of the balloon. In someembodiments, the balloon may be made up of a combination of foil andmesh materials with different thicknesses. This structure provides forsuperior dilatation, load-bearing, permeability for primaryfixation/adjacent augmentation, and degradation properties over balloonsin the prior art.

The balloons may be used to treat any bone or disc with an interiorlesion or cavity sufficiently large to receive the balloon. Non-limitingexamples of bones that are suitable candidates for anatomicalrestoration using the device and method of the embodiments includevertebral bodies, the medullary canals of long bones, the calcaneus andthe tibial plateau. The balloon can be designed and adapted toaccommodate particular bone or disc anatomies and different cavityshapes, which may be made in these and other suitably large bones.

The material of the balloon is selected based on the intended purpose ofthe balloon. For example, if one of the volumes of the balloon is usedto lift a vertebral body by occupying the intervertebral disc space, orprovide a cushioning/dampening effect, the material may be more elasticin order to permit variances in volumes as needed. The balloon may alsobe made of a rigid or non-elastic material, such as, for example, foilor foil coated with a protective material. The balloon may bethick-walled to contain liquids for an extended period of time, i.e.,beyond the lifting of a vertebral body or disc. The multi-volume balloonmay be designed and configured to be deployed and remain in the bonecavity for an extended period of time. Balloons can be made of anysuitable material to provide for inflation and/or stabilization, suchas, for example, foil, mesh, silicone rubber, elastomeric rubber,polyether ether ketone (or PEEK), polyether ketone ketone (or PEKK),polyethelyene (or PE), polyurethane (or PU), polycarbonate urethane (orPCU), polyethylene terephthalate (or PET), thermoplastic polyurethane(or TPU), etc. Any one of a diverse set of polymers is preferred.Balloon materials for temporary use may include polyamides (or PA) andco-polymers thereof, e.g., polyether-block-amide (or PEBA, Pebax),allowing for suitable balloon material compliance tuning. In someembodiment, the balloon can be a circuit board containing printed blackmarks, wherein the marks are bonded together upon exposure toheat-generating light: the light is absorbed only by the marks (or blacklines), generating local heat and hence bonding at that site, otherwisethe light is transmitted through the substantially transparent balloon.A balloon made with softer, more elastic substances is better forcorrecting load distribution while a harder balloon is better forrealignment and space maintenance. In another embodiment, the balloonmay be biologically resorbable. Biologically resorbable balloonmaterials may include polylactides, magnesium alloy components, etc.

Once filled, the balloon is allowed to remain within the intervertebraldisc space or bone for a prescribed period of time or perhapsindefinitely. The duration of time that the balloon remains within thebone may depend upon specific conditions in the treated bone and theparticular objective sought by the treatment. When the balloon isimplanted for a short period of time, it functions as an instrument increating space, or lifting the vertebral body, hence enabling loadbearing and/or sharing along the spinal column axis. Alternatively, theballoon functions as an implant when it remains in the patient forlonger periods of time. The balloon may remain within the cavity forprescribed periods of time that include, for example, an hour, a day,several days, weeks, months, or years, or even may remain within thebone permanently.

The balloon content material can be any one or a combination of a numberof: liquids, such as, for example, water, saline solutions, radiopaquecontrast medium solutions; elastic-type contents, such as, for example,elastomers (especially silicone-based), hydrogels, silicone; rigidcontents, such as, for example, polymethyl methacrylate (PMMA),hydroxylapatide-based materials, calciumphosphate-based materials, andother bone cements; particles, such as, for example, bone, polymers,bone chips in a liquid; and bio-absorbable materials. Bone cements mayprovide a rigid construct or be elastic; both the rigidity andelasticity may be reached in-situ via a chemical reaction, such aspolymerization or crystallization reactions. Solidifying materials mayalso be used to provide a rigid construct, such as, for example:polymers, crystalline solids, elastomers, and glass. Aqueous liquids(such as saline, contrast media, mixes thereof, etc.) as well aselastomers provide a dampening cushion. The dampening cushion providedby the device is designed to restore any weakened/damaged structuresthat are adjacent to the balloon, as well as to protect anyintact/healthy structures that are adjacent to the balloon. A problemwith the currently used devices, which fuse two vertebral bodiestogether, is eventually the fused vertebral bodies create the same issuein the nearby discs because the fused bodies compensate for the lack ofan intervertebral disc by overloading the nearby discs. In contrast,embodiments of the balloon provide a dampening effect by creating acushion and restoring the adjacent vertebral bodies.

In an alternative embodiment, some compartments of the balloon mayprovide a dampening cushion and other compartments provide a rigidconstruct. In this embodiment, the dampening compartments may be filledwith a greater volume of contents than the rigid compartments. Forexample, if the cavity experiences a sudden increase in pressure and iscompressed, the greater filled dampening compartments absorb the shockof the increase in pressure and the lesser filled rigid compartmentsprevent the height of the cavity from decreasing below the height of therigid compartment.

The content material can also be a two-component mixture, for example,bone chips with a hardening agent. Liquids are possible, but notrecommended because liquids render critical both seals and valves. Athick-walled balloon is recommended if the balloon will be filled withliquid and implanted for an extended period of time. A seal, or bonding,according to an embodiment creates a leak-proof closure to prevent thecontents of the balloon from leaking out. One embodiment involvesinserting a liquid into the balloon, where the expanded balloon is usedas an instrument to lift the vertebral body to a desired height. Theliquid is then removed from the balloon (i.e., balloon deflation) andthe balloon is removed (i.e., balloon retrieval) from the patient. Onceheight is restored, a bone cement, a cage, or any other device can beinserted to occupy the space created by the balloon, provided there isno collapse of the created space.

In some embodiments, the content material can be heated above bodytemperature (about 98.6° F.) so that it hardens faster (approximately140° F.-160° F.); applied heating accelerates hardening of the contentmaterial. The content material is heated, rather than the entire balloonor even the walls of the balloon. An example of a preferred contentmaterial that can be selectively heated includes PMMA. The heat can beselectively applied to the content material of discrete volumes of theballoon. A heat probe can be affixed to the device to accelerate thechemical reaction in order to harden the contents of the balloon. Theheat can be applied after insertion of the multi-volume balloon into thepatient. A benefit is that once the balloon is filled, it can remainwithin the body of the patient. The content material hardens, either bybody temperature alone or by the application of additional heat toharden the contents within the balloon; this eliminates the concern ofleakage of the material from the balloon because it is a hardenedmaterial, especially if the balloon is to remain within the body for anextended period of time. The contents of the balloon must bebiocompatible because of potential mechanical degeneration or tearing ofthe balloon itself, if implanted for the long term. Alternatively, theentire balloon is heated because the heat may not alter the balloon wallwhile the contents are hardened.

The content material is provided under precise pressure and volumecontrol. In a preferred embodiment, the balloon is inflated directlyagainst the bone to be restored. This would cause the deployed balloonto press the damaged bone into a configuration that reduces fracturesand restores the anatomy of the damaged bone.

A method according to an embodiment includes customizing the contents ofthe balloons based upon the stage of disc degeneration in a patient orbased on the progression of degeneration. In early-stage degeneration,it is preferable that the content material be a saline solution,hydrogel, elastomer (or elastomer cement), or silicone-type material. Inearly stages of degeneration, the method provides a stabilization of thetreated level and an adjacent level of protection. In mid-level stagesof disc degeneration, preferred content material includes bone cements;rigid compound materials, such as, for example, hydroxylapatide-basedmaterials and calciumphosphate-based materials; and particulatematerials. In mid-level stages of degeneration, the method provides fora rigid construct to allow for bony fusion to occur. In late stages ofdisc degeneration, preferred content materials include bone cements andrigid compound materials, such as, for example, hydroxylapatide-basedmaterials and calciumphosphate-based materials. In late stages ofdegeneration, the method provides for a rigid filling that completelycovers the endplate of the vertebral body and, due to a permeabilitytowards the vertebral body endplates, allows for penetration of fillerthrough the endplates into the vertebral bodies that results in primarystabilization and augmentation. Determining the necessary contents maybe difficult because of the progression of disc degeneration fromearly-, to mid-, to late-stages of degeneration. One purpose of themethod is to match the contents of the balloon to the progression of thedisease or disc degeneration. The content material in the balloon mightbe removed and replaced with a different filler as the diseaseprogresses.

In addition, the outer surface of the balloon may be treated with acoating or texture to help the balloon become more integral with thesurrounding bone matter or to facilitate acceptance of the balloon bythe patient. The selection of balloon materials, coatings, and texturesalso may help prevent rejection of the balloon by the body. Likewise,the outer surface of the balloon may be treated with a coating ortexture to help the balloon become more puncture and tear resistant. Theinner surface of the balloon likewise may be textured or coated toimprove the performance of the balloon. For instance, the inner surfaceof the balloon may be coated or textured to increase adhesion betweenthe balloon wall and the material inside or, alternatively, to preventcontact between the balloon wall and the content material if, forexample, the balloon wall material and contents were physically orchemically incompatible.

The balloon is inserted into a bone cavity or disc space that has beenprepared to allow the balloon to be placed in the disc space or near thedamaged bone. In some embodiments, the cancellous bone tissue and bonemarrow inside the bone and in the area to be treated may be cleared orcompressed away from the region in advance of deploying the balloon.Clearing the treated region may be accomplished by either shifting orrelocating the cancellous bone and marrow to untreated regions insidethe bone, or by removing the materials from the bone by using a reameror some other device. In embodiments where the space is cleared beforeinsertion of the balloon, less resistance is needed to unfurl or expandor otherwise deploy the balloon. In the disc space, alternatively, adiscectomy can be performed to remove the intervertebral disc. Thesemethods are particularly useful in embodiments where devices to promotefusion are inserted after the balloon. In some embodiments, the balloonis the device that is inserted to promote fusion.

In addition, the bone cavity or disc space may be irrigated or aspiratedto permit balloon implantation and to create an environment suitable forbone growth. Preferably, the aspiration would be sufficient to removecancellous bone or disc material within the region to be restored. Morepreferably, a region exceeding the extent of the fully deployed balloonby about 2 mm to 4 mm would be aspirated in this manner. Clearing thecavity of substantially all bone marrow near or within the treatedregion may prove especially useful for restoring the bone andincorporating the balloon as a prosthetic device to remain in thecavity. Pre-clearance of material within the cavity provides fordecreased resistance when the balloon is inflated within the cavity.U.S. Pat. No. 6,679,886 to Weikel, et al. entitled “Tools and methodsfor creating cavities in bone” (the contents of which are incorporatedby reference) describes a method for creating cavities in bone. Inanother embodiment, the intervertebral disc or disc space does not needto be cleared out before placing the balloon in the disc space. In thisembodiment, a guide wire, preferably a pre-bent guide wire, guides theballoon to the disc space and expands the balloon inside the lesionsite, compressing any tissue or bone around the balloon.

A challenge in the art is a posterior approach to the vertebral discthat has a very limited path during surgery, especially if the toolsused by the surgeon are all straight tools. The surgeon must navigatearound corners and has a difficult time gaining access to the entirevertebral disc and placing any device in the proper location of theintervertebral disc. Therefore, the method involves the steps ofintroducing the balloon in a deflated state, with a reduced profile, andthen inflating the balloon once it is delivered to the desired location.Still another solution to this problem is achieved by inserting thedevice in a deflated state with small diameter equipment; therefore, asurgeon can use a posterior approach to insert the balloon and avoid thelimitations of an anterior approach.

In some embodiments, a cavity may be pre-created by inserting a balloon,such as a simple spherical balloon, into the cavity of the patient. Inthis embodiment, the balloon is inserted into the patient, the balloonis expanded, thus creating the cavity, and removed. A balloon accordingto this embodiment is then inserted into the pre-created cavity and canbe inserted, unfurled, expanded, and/or otherwise deployed into thecavity of the patient. The balloon meets much less resistance in thepre-created cavity than it would in a cavity that is filled with tissue,cartilage, bone, etc.

Note that access is paved for the balloons using a posterior minimallyinvasive surgery (MIS) approach via a 3 mm to 10 mm diameter cannula, oreven using a posterior percutaneous approach of only 1 mm to 4 mm. Adevice inserted via a posterior approach is limited in size by theinterval between the nerve roots. Therefore, the balloon is expandedfrom within the intervertebral space or cavity to reduce potentialtrauma to the nerve roots and yet still allow restoration of disc spaceheight. Alternatively, a surgeon can use a lateral, anterior-lateral, oranterior approach to introduce the balloon because the balloon isintroduced in a deflated state and the tools are minimal in diameter andtherefore the risk of an interference with sensitive soft tissues suchas nerves is reduced.

In some methods, the balloon can be rolled into a tubular shape outsidethe body of the patient; the shape of the balloon is selected, or theballoon is bonded into its shape and connected to the other componentsof the balloon-catheter before it is rolled into a tubular shape, andkept in that furled up state by sliding a cover sleeve onto it. Theballoon is then inserted into the body through a working sleeve or othertube-shaped cannula, and then unfurled once inside the body, orappropriate cavity, of the patient. Alternatively, the balloon can berolled around a guide wire outside the body of the patient and thenunfurled once inside the body, or appropriate cavity, of the patient.This method allows the balloon to be inserted with a low profile, in atubular shape, and then unfurled into a flat shape because the balloonis not yet inflated. The rolled balloon can be inserted into a cavitythat is pre-created or cleared, according to any of the methodsdescribed above, to encounter less resistance when it is unfurled orexpanded. The balloon, or the individual compartments of the balloon,are then inflated with any of the contents necessary to restore theproper anatomy of the patient.

FIG. 1 is a perspective view of a kit used to form a multi-volumeballoon from a single-volume balloon. A single-volume balloon 2 isprovided in the kit along with at least one ring 5. Preferably, the kitincludes a variety of rings 5 of different geometric characteristics.FIG. 1 A shows that the example ring 5 has an angle 7 on its right endand an angle 9 on its left end. Angle 7 and angle 9 of the ring 5determine the orientation and angle of each volume of a multi-volumeballoon; the volume takes the angulation of the ring 5. Angle 7 andangle 9 of the ring 5 can be set to a predetermined angle. By“predetermined” is meant determined beforehand, so that thepredetermined angle must be determined, i.e., chosen or at least known,in advance of inserting the ring 5 onto the single-volume balloon 2. Asis shown in FIG. 1B, FIG. 1C, FIG. 1G, FIG. 1I, and FIG. 1K amulti-volume balloon 10 has ring 5 with angle 7 and angle 9. Once ring 5is inserted onto the single-volume balloon 2, multi-volume balloon 10 iscreated.

In one embodiment, the ring 5 can be adjusted once the single-volumeballoon 2 is expanded and the multi-volume balloon 10 is formed. Inanother embodiment, the ring 5 does not move once mounted and themulti-volume balloon 10 is formed. In yet another embodiment, the kit isprovided with the ring 5 pre-mounted onto the single-volume balloon 2.

As is shown in FIG. 1B and 1C, multi-volume balloon 10 is made up of twovolumes, volume 10A and volume 10B. The amount of contents of volume 10Aand volume 10B depend upon the location of ring 5 along the length ofthe single-volume balloon 2 and the angle 7 and angle 9. A surgeon candetermine the amount of volume needed in the multi-volume balloon 10either before or during surgery. The ring 5 can be adjusted to vary theangle and capacity of volume 10A and volume 10B of the multi-volumeballoon 10. In accordance with this embodiment, more than one ring 5 canbe placed on the single-volume balloon 2 to create more than twovolumes. As shown in FIG. 1A, the size of ring 5 and angles 7 and 9 canbe selected to meet the needs of a particular patient and application.The number of volumes that form multi-volume balloon 10 can vary basedon the number of rings. FIG. 1E is a multi-volume balloon 10 that hasthree volumes, 10A, 10B, and 10C; FIGS. 11 and 1G are multi-volumeballoons 10 with five volumes and six volumes, respectively.

FIG. 1B, FIG. 1C, FIG. 1E, FIG. 1G, and FIG. 1I are perspective views ofmulti-volume balloon 10. As is shown in FIG. 1B, FIG. 1C, FIG. 1E, FIG.1G, and FIG. 1 I, multi-volume balloon 10 has a closed end 15 and asealed end 17. Closed end 15 is distal to the surgeon and/or insertioninstrument and prevents the release of contents from the multi-volumeballoon 10. Sealed end 17 is proximal to the surgeon and/or insertioninstrument. Single volume balloon 2 is inflated, and createsmulti-volume balloon 10, by connecting inflation end 18 with aninsertion device, such as, for example, an injection syringe (e.g., apressure syringe with a manometer that takes volumetric readings whilemulti-volume balloon 10 is being inflated). Contents that are used toinflate multi-volume balloon 10 through inflation end 18 depend upon thespecific needs of the patient and can include non-rigid or rigidcontents, as described above. Temporary implants, such as a multi-volumeballoon 10, are filled with saline, aqueous, or other non-rigid contentsafter inflation of the multi-volume balloon 10. Inflation end 18 of theballoon is then disconnected from the insertion instrument and sealedend 17 created by sealing the proximal end of the multi-volume balloon10 with a valve, for example, to prevent the release of contents fromthe multi-volume balloon 10. Permanent implants, such as a multi-volumeballoon 10, are filled with hardened bone cement, e.g., PMMA or otherrigid contents. Inflation end 18 of the balloon 10 is then disconnectedfrom the insertion instrument and sealed end 17 is created by severingand disconnecting the proximal end of the multi-volume balloon 10 fromthe insertion instrument.

FIG. 1D, FIG. 1F, and FIG. 1H are perspective views of a single volumeballoon 2 with varying numbers of rings 5 to create different numbers ofvolumes of the multi-volume balloon 10 after the balloon is inflated. Aninsertion instrument is connected to the proximal inflation end 18.Distal closed end 15 is closed before inserting contents into the singlevolume balloon 2 to prevent the contents from being released. And thecontents are inserted into the single volume balloon 2 to create themulti-volume balloon 10. Angle 7 and angle 9 of the ring 5 provide forvarying shapes of multi-volume balloon 10.

Inflation of the single volume balloon 2 shown in FIG. ID results in amulti-volume balloon 10 having a kidney, or banana shape, shown in FIG.1E. In another embodiment, inflation of single volume balloon 2 shown inFIG. 1F results in a multi-volume balloon 10 having a snake-like form,shown in FIG. 1G. In yet another embodiment, single volume balloon 2,shown in FIG. 1H, is covered with a cover sleeve 19 that constrains thesingle volume balloon 2. As contents are inserted through inflation end18 and into the single volume balloon 2, shown in FIG. 1H, the coversleeve 19 initially constrains the expansion of the single volumeballoon 2. The closed end 15 of the single volume balloon 2 unwinds asit exits the cover sleeve 19 at the distal end. As the single volumeballoon 2 exits the cover sleeve 19 it is then unconstrained by thecover sleeve 19, and the multi-volume balloon 10, as is shown in FIG.1I, is formed having a twisted configuration.

In some embodiments, the ring 5 is made of a metal, such as stainlesssteel or titanium, that can act as a marker. In another embodiment, ring5 is made of a material to act as an x-ray marker, such as a cobaltchrome alloy. In another embodiment, the ring 5 is made of a polymer,rendering the ring more compatible for magnetic resonance imaging (MRI)technologies. It is also possible to make the ring 5 of PEEK. PEEK is asemi-crystalline thermoplastic with excellent mechanical and chemicalresistance properties that are retained to high temperatures. Therefore,PEEK is considered an advanced biomaterial used in many medical implantapplications.

The ring 5 can comprise a one-way valve, namely, that allows a liquid toflow only in one direction and not the opposite direction. A simplemembrane can also function as a one-way valve. The specific one-wayvalve can be selected, as within the skill of an artisan, to meet theneeds of a particular patient and application.

In order to further reduce the diameter of the balloon, the balloons canbe attached to the ring 5 by welding, gluing, stitching or any otherbonding method known in the art. As is shown in FIG. 1J, ring 5 isbonded to multi-volume balloon 10 at a bonding site 12 and a bondingsite 14. In an alternate embodiment, as is shown in FIG. I K, singlevolume balloon 2 and a single volume balloon 3 are bonded to ring 5 atbonding site 12 and bonding site 14.

FIG. 2A is a top view and FIG. 2B is a side view of a single ormulti-volume balloon according to another embodiment. FIG. 2A shows twolayers of uncut foil 20 placed on top of each other. In FIG. 2A the twolayers of uncut foil 20 are in a rectangular shape, but the shape of theuncut foil 20 can be any shape, such as, for example, circular,triangular, square, or oval. The two layers of uncut foil 20 are scoredwith marks 24. The intersection of the marks 24 can create individualvolumes 26, 28, 30 throughout the uncut foil 20. A balloon 22 is createdfrom the uncut foil 20 by bonding the two layers of the uncut foil 20together. The layers can be bonded together by methods known in the art,such as, for example, welding, heat, glue, stitching, friction, laserbeam technologies, laser beam technologies with an additional absorptionmedium, ultrasonic technologies, and energy beam methodologies. Balloon22 can be cut out of the uncut foil 20 in any shape that is necessary tofill a cavity of a patient. The perimeter of the balloon 22 is bondedtogether, as discussed above. In some embodiments, the balloon 22 ismanufactured in a desktop printer-like device. The uncut foil 20 can bemade of polymers or metal. In some embodiments, the uncut foil 20 can bemade of a mesh material that can be made of polymers or metal to allowfor permeability. The metal can consist of a metallic thin film,preferably made from shape-memory alloy, such as, for example, nitinol.In another embodiment, the uncut foil 20 can be a circuit boardcontaining printed black marks, wherein the marks are bonded togetherupon exposure to heat-generating light; the light is absorbed only bythe marks (or black lines), generating local heat and hence bonding atthat site, otherwise the light is transmitted through the substantiallytransparent foil.

This embodiment can be customized to fill the cavity of a patient. Thecompartments of the uncut foil 20 or balloon 22, created by the marks24, can be selectively filled or left empty, depending on the specificneeds of the patient. This provides for a varying topography andinfinite possibilities for what compartments to fill, which to leaveempty, and what contents to provide to each of the compartments.

The compartments may be filled with different materials, depending uponthe needs of the patient. For example, some compartments (for example,compartments 26 and 30) may be filled with water, saline, contrast mediasolution, or similar type substances, to provide for a cushioning ordampening effect (“cushioning compartments”). Other compartments (forexample, compartment 28) may be filled with a hard material, such as apolymer or bone cement, to provide support and height and act as astopper (“support compartments”). In this embodiment, the cushioningcomponents may contain more material than the support compartments sothat if, the cavity experiences sudden pressure, the cushioningcompartments provide flexibility to dampen the shock, while the supportcompartments act as a stopper to prevent the height of the balloon 22from minimizing below the height of the support compartment. Thecompartments can be filled once the balloon 22 is inserted into thecavity of the patient.

In another embodiment, the compartments located closest to the perimeterof the balloon 22 can be support compartments, as discussed above, andthe compartments in the interior of the balloon can be cushioningcompartments. In this embodiment, the support compartments providesupport and height, as discussed above, but also act as a stopper, orboundary, for the filing in the cushioning compartments. The supportcompartments are not limited to the perimeter of the balloon 22, but canbe arranged in any pattern in the balloon to act as a boundary for thefilling in the cushioning compartments.

In some embodiments, the contents of the compartments may be changedover time. A compartment that was previously empty can be filled at alater time, or a compartment that was a cushioning compartment can havethe contents removed, filled with a hard material, and be converted to asupport compartment.

FIG. 2B is a side view of an alternative embodiment. In FIG. 2B, themarks 24 of the uncut foil 20 did not create individual compartments,but rather after balloon 22 was bonded, a single volume balloon 40 wascreated. A bonding 42 is the site where the uncut foil 20 was bondedalong the shape outlined for the balloon 22.

The layers of the uncut foil 20 can be bonded either duringmanufacturing, or before insertion into a patient or even duringsurgery, allowing for intra-operative customization of the shape andsize of the implant. In this embodiment, the patient may undergo apre-surgical evaluation to determine the size of the balloon 22 neededto fill the cavity. In some embodiments, the uncut foil 20 or balloon 22can be curled around a guide wire or insertion instrument and guided toa cavity of the patient. In this embodiment, the balloon 22 is notinflated before insertion. This allows the balloon to be inserted with alow profile. The uncut foil 20 or balloon 22 is then unfurled within thecavity; the balloon 22 may then be bonded from the uncut foil 20. Thesurgeon then determines what individual compartments to fill, oralternatively, the whole balloon 40 may be expanded, in order to provideselective lifting power and height restoration, depending on the needsof the patient.

The anatomical situation of the patient, and the varying possibilitiesfor filling the compartments of the uncut foil 20, provide an array ofthree dimensional shaped balloons that are individually created for eachpatient.

FIG. 3 is a perspective view of a single or multi-volume balloonaccording to another embodiment. A multiple-bond balloon 50 is createdby bonding together three or more sheets of foil 56A, 56B, 56C along thebonding sites 52. In some embodiments, the multiple-bond balloon 50 ismanufactured in a desktop printer-like device. The layers can be bondedtogether by methods known in the art, such as, for example, heat, glue,stitches, friction, pressure, laser beam technologies, laser beamtechnologies with an additional absorption medium, ultrasonictechnologies, and energy beam methodologies. The multiple-bond balloon50 provides for an array of 3-dimensional free shaped balloons that arenot limited to an oval or spherical shape of a single volume, or theshape of a single-bond balloon. The foil sheets 56A, 56B, 56C ofmultiple-bond balloon 50 can have marks 54 that create individualcompartments as described with reference to FIG. 2A and FIG. 2B above.The compartments can be selectively filled to create a unique anatomicshape and consistency as described above. Each compartment can be eitherunfilled or filled; the filled compartments can be filled with materialthat provides either a cushioning or support effect for the patient. Insome embodiments, the compartments can be filled in a maze-like fashion,e.g., located on a second plane that is parallel to the balloon plane.

FIG. 4A, FIG. 4B, FIG. 5A, and FIG. 5B are perspective views of amulti-volume balloon according to additional embodiments. These figuresshow a multi-volume balloon 80 with a lifting volume 82 and a fillingvolume 84. In some embodiments, the locations of lifting volume 82 andfilling volume 84 can be reversed. The multi-volume balloon 80 maycomprise more than one lifting volume 82 and more than one fillingvolume 84 to obtain a desired height and stabilization. According tothis embodiment, lifting volume 82 is filled with a substance that iseasy to remove, such as saline. The lifting volume 82 is filled tocreate height (e.g., re-create the height of a disc space) or lift anyfractures in a cavity of bone. Once the desired height is achieved, thecontents inside lifting volume 82 are removed. Contents are theninjected into filling volume 84 to maintain the volume created bylifting volume 82. Preferred contents for insertion into filling volume84 include those that would make filling volume 84 rigid, such as apolymer or bone cement.

The combination of separate lifting volume 82 and filling volume 84offers significant advantages. One advantage is better loaddistribution. Another advantage is better control when lifting andre-creating the disc space. In summary, the combination of two, separatevolumes having different functions is better than using one volume toachieve both functions (which inherently requires tradeoffs).

FIG. 4B shows lifting volume 82 and filling volume 84 separated by abonding site 88 that is created by two foils bonded together. The foillayers can be bonded together by methods known in the art, such as, forexample, heat, glue, friction, laser beam technologies, laser beamtechnologies with an additional absorption medium, ultrasonictechnologies, and energy beam methodologies. The multi-volume balloon 80in FIG. 4B is formed of a foil material. The foil material provides afree-form balloon for the surgeon. In other embodiments, themulti-volume balloon 80 is formed of a mesh material.

FIG. 5A shows a multi-volume balloon 80 that contains lifting volume 82and filling volume 84 separated by a perforation 90. Perforation 90provides a controlled break for separation of lifting volume 82 fromfilling volume 84 at a pre-determined breaking point.

FIG. 5B also contains a perforation 90 to permit a controlled breakbetween lifting volume 82 and filling volume 84. Multi-volume balloon 80as shown in FIG. 5B further contains a guidewire 92 that is attached tomulti-volume balloon 80. Guidewire 92 provides for control in theinsertion and placement of multi-volume balloon 80 in a cavity of bone.Guidewire 92 can be removed by tearing off perforation 90. In someembodiments, guidewire 92 can include a sensor or light source.

In alternative embodiments, the locations of filling volume 84 andlifting volume 82 can be reversed. Any lumen of the multi-volume balloon80 shown in FIG. 5A and FIG. 5B can be the lifting volume or the fillingvolume. It may not be predetermined which volume is the filling volume84 and the lifting volume 82. All volumes of the multi-volume balloon 80are finable with any contents discussed above.

Lifting volume 82 creates additional space in the cavity for bony fusionand can be removed, but does not have to be removed, from themulti-volume balloon 80. In alternative embodiments, lifting volume 82can be filled to create space. Subsequently, filling volume 84 can befilled with any contents as discussed above and lifting volume 82 can beemptied. At any time point later, lifting volume 82 can be filled with adifferent content to provide support or cushioning to the patient, orremoved by tearing at the perforation 90, dependent upon the patient'sneeds.

Although the invention has been described with reference to certainpreferred embodiments, it should be kept in mind that the scope of theinvention is not limited to these embodiments. The balloon can bemodified or extended to accommodate particular formulations of balloonconstruction materials or fabrication techniques. Similarly, the numberand spacing of the single volumes of the multi-volume balloon may bechanged to better accommodate the cavity. Different balloon materialsand surface coatings, or outer layers of different materials or surfacecoatings, may also be applied to the balloon to facilitate a smallerballoon profile for deployment. The embodiments above can also bemodified so that some features of one embodiment are used with thefeatures of another embodiment. One skilled in the art may findvariations of these preferred embodiments which, nevertheless, fallwithin the spirit of the invention, whose scope is defined by the claimsset forth below. It is also expressly intended that the steps of themethods of using the various balloons disclosed above are not restrictedto any particular order.

1. A multi-volume balloon for treating clinical consequences ofdegenerative disc disease, vertebral body bone defects, and spinalmotion segment instability comprising a plurality of single volumes eachconnected, directly or indirectly, to one another, wherein a perforationsite is located between at least two of the single volumes, and whereineach single volume is individually adjustable and expandable such that(a) each single volume can contain a variable volume of contents, and(b) each of the plurality of single volumes can contain the same, or adifferent, amount and type of contents relative to another singlevolume.
 2. The multi-volume balloon according to claim 1, wherein theperforation site contains a guidewire.
 3. The multi-volume balloonaccording to claim 1, wherein the single volumes are compartments of atleast two pieces of foil bonded together at the perforation site,wherein the bonding is selected from the group consisting of: ultrasonicwelding, thermal welding using a light source, thermal welding using aheat source, pressure welding, swaging, joining, gluing, and stitching.4. The multi-volume balloon according to claim 1, wherein the materialis selected from the group consisting of: foil, mesh, tube, siliconerubber, elastomeric rubber, polyether ether ketone (or PEEK), polyetherketone ketone (or PEKK), polyethelyene (or PE), polyethelyeneterephthalate (or PET), polyurethane (or PU), thermoplastic polyurethane(or TPU), and polycarbonate urethane (or PCU).
 5. A balloon for treatingclinical consequences of degenerative disc disease, vertebral body bonedefects, and spinal motion segment instability comprising at least twopieces of material that are bonded together to form a balloon, whereinthe material contains marks, wherein the marks can be bonded together toform at least two compartments in the balloon.
 6. The balloon accordingto claim 5, wherein the balloon is formed from at least three pieces ofmaterial that are bonded together.
 7. The balloon according to claim 5,wherein the material is selected from the group consisting of: foil,mesh, fabric, tube, silicone rubber, elastomeric rubber, polyether etherketone (or PEEK), polyether ketone ketone (or PEKK), polyethelyene (orPE), terephthalate (or PET), polyurethane (or PU), thermoplasticpolyurethane (or TPU), and polycarbonate urethane (or PCU).
 8. Theballoon according to claim 5, wherein the at least two compartments areindividually adjustable and expandable such that (a) each compartmentcan contain a variable volume of contents, and (b) each of thecompartments can contain the same, or a different, volume of contentsrelative to another compartment.
 9. The balloon according to claim 5,wherein the material comprises a circuit board containing printed blackmarks, wherein the marks are bonded together upon exposure toheat-generating light. 10.-12. (canceled)
 13. A method of aligning andstabilizing a vertebral column, the method comprising: inserting aballoon-catheter containing a multi-volume balloon, wherein themulti-volume balloon is located at the distal end of theballoon-catheter, into a cavity of a vertebral column, wherein thecavity is selected from the group consisting of an intervertebral discspace and a space in a vertebral body; expanding a first volume of themulti-volume balloon by inserting a fluid, wherein the expansion of thefirst volume restores height to the vertebral column; and expanding asecond volume of the multi-volume balloon by inserting a solidifyingmaterial, wherein the solidifying material hardens after insertion tomaintain the height restoration created by the expansion of the firstvolume
 14. The method according to claim 13, wherein the fluid isselected from the group consisting of: water, saline solution, contrastmedium solution, and gel.
 15. The method according to claim 13, whereinthe solidifying material is selected from the group consisting of:polymer, crystalline solid, elastomer, and glass.
 16. The methodaccording to claim 13, wherein the multi-volume balloon contains aperforation site and the perforation site contains a guide wire tofacilitate detachment of at least one of the volumes of the multi-volumeballoon.
 17. The method according to claim 16 further comprising: afterinflating the second volume of the multi-volume balloon tearing alongthe perforation site to remove the first volume; retracting and removingthe first volume from the cavity of the vertebral column; and retainingthe second volume of the multi-volume balloon containing the hardenedpolymer to maintain the height restoration created by the expansion ofthe first volume.
 18. The method according to claim 13, wherein thefirst volume and second volume are expanded to different heights. 19.The method according to claim 18, wherein the expansion of the firstvolume is also to provide a cushioning effect, and wherein the firstvolume is expanded to a height greater than the second volume.
 20. Amethod for inserting a balloon into a cavity of a patient, the methodcomprising: rolling the balloon into a tubular shape; inserting theballoon into the cavity of the patient, wherein the cavity was clearedprior to insertion of the balloon; and unfurling the balloon once insidethe cavity.
 21. The method according to claim 20, wherein the balloonhas a shape that is selected prior to rolling the balloon into thetubular shape.
 22. The method according to claim 20, wherein the balloonis rolled into a tubular shape around a guide wire.
 23. The methodaccording to claim 20, wherein the balloon is inserted into the cavitythrough a cover sleeve.
 24. (canceled)
 25. (canceled)